PCN — Immunoglobulin G Kappa Heavy And Light Chain Combined Class II
FDA product code PCN covers "Immunoglobulin G Kappa Heavy And Light Chain Combined", a Class II medical device regulated under 21 CFR 866.5510. Submissions are reviewed by the Immunology panel. At least 3 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- PCN
- Device Class
- Class II
- Regulation Number
- 866.5510
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Immunology
- Implant
- No
Definition
Intended for the in-vitro quantification of IgG kappa concentration in human serum.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K172613 | binding site group | Optilite Hevylite IgG Kappa Kit, Optilite Hevylite IgG Lambda Kit | February 15, 2018 |
| K161854 | binding site group | Hevylite Human IgG Kappa Kit for use on the SPAPLUS, Hevylite Human IgG Lambda K | October 4, 2016 |
| K132555 | binding site | HEVYLITE HUMAN IGG KAPPA KIT AND HEVYLITE HUMAN IGG LAMBDA KIT | December 20, 2013 |